Home / Recalls / Vapotherm / Z-1272-2023

Z-1272-2023 Class II Ongoing

Recalled by Vapotherm — Exeter, NH

Recall Details

Product Type
Devices
Report Date
March 29, 2023
Initiation Date
December 16, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5869 total

Product Description

Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW

Reason for Recall

There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of UK.

Code Information

UDI-DI: 00841737104971, Lot Numbers: LFVMA8503, LFVMA8504, LFVMA8567; UDI-DI: 00841737104978, Lot Number: LFVLE8568 Additional Lot Numbers: LFTL41015 LFVLC8399 LFVLE8495 LFVMA8502 LFVMA8503 LFVMA8504 LFVMA8567 LFTL41261 LNTL41544 LFVLE8588 LFVMA8507 LFVLE8568 LFVLE8494 LFTL41263 LFTL41262

Other recalls by Vapotherm

  • Z-2699-2014 Class II — Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with (August 13, 2014)
  • Z-2700-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with (August 13, 2014)
  • Z-2704-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low p (August 13, 2014)
  • Z-2701-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with (August 13, 2014)
  • Z-2706-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use wi (August 13, 2014)
  • Z-2702-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with (August 13, 2014)
  • Z-2705-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with (August 13, 2014)
  • Z-2703-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with t (August 13, 2014)